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Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemod...

FDA Recall #Z-0764-2023 — Class II — November 23, 2022

Recall #Z-0764-2023 Date: November 23, 2022 Classification: Class II Status: Ongoing

Product Description

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reason for Recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,140,096 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.

Code Information

No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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